510(k) · Cleared
ClearedMaggi Series Ultra. Needle, Biopsy/Catheter Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CIVCO Medical Instruments Co., Inc. · DWZ Device, Biopsy, Endomyocardial
Cleared on Nov 28, 1988 after a 172-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 369 devices in its family, counting itself, have a Class I recall. 368 later devices descend from it.
- Decided
- Nov 28, 1988
- Review
- 172 days
- Class
- Class II
- Product code
- DWZ
- Recalls
- None
- Predicates
- 0
368 later devices descend from it, 4 citing it directly. 2 of the 369 devices in this family, counting this one, have a Class I recall.
- This deviceK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
- Descendant · cites it directly · 358 of its ownK974432 Ultraguide 1000Ultraguide, Ltd. · 1998
- Descendant · 2 generations on · 280 of its ownK023227 USG 2000SAUltraguide, Ltd. · 2002
- Descendant · 2 generations on · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
- Descendant · 4 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
Showing 5 of 368 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 368 · See all- K974432Ultraguide 1000Ultraguide, Ltd. · 1998 · cites it directly358descendants
- K023227USG 2000SAUltraguide, Ltd. · 2002 · 2 generations on280descendants
- K053610AbarisTraxtal Technologies, Inc. · 2006 · 2 generations on278descendants
- K121498PercunavPhilips Health Care · 2012 · 3 generations on222descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 4 generations on211descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter Guides | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| +1 | K974432 | Ultraguide 1000 | Ultraguide, Ltd. | 1998 | — |
| +2 | K023227 | USG 2000SA | Ultraguide, Ltd. | 2002 | — |
| +2 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| +3 | K121498 | Percunav | Philips Health Care | 2012 | — |
| +4 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 15 | 0 |
| 2015 | 20 | 0 |
| 2016 | 21 | 0 |
| 2017 | 37 | 0 |
| 2018 | 24 | 0 |
| 2019 | 20 | 0 |
| 2020 | 34 | 0 |
| 2021 | 29 | 0 |
| 2022 | 28 | 0 |
| 2023 | 22 | 0 |
| 2024 | 25 | 0 |
| 2025 | 36 | 2 |
| 2026 | 28 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DWZ device
- #1 K252722 Biopsy Forcepsscore 10.7 · 3 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (368)
See all 3684 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974432 | Ultraguide 1000 | 1998 | 358 |
| K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal… | 2009 | 61 |
| K093713 | Ultrasound General Purpose Guidance System | 2010 | 4 |
| K043425 | Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based… | 2005 | 4 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K974432 (Ultraguide, Ltd., 1998) has gone furthest, with 358 descendants of its own.
How does its category compare?
All DWZ devicesDWZ Device, Biopsy, Endomyocardial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWZ
Too few DWZ 510(k)s in any year since 2007 to give a median.
Recalls per year · DWZ
No recall names DWZ since 2007.
Adverse event reports per year · DWZ
1in 2025
MAUDE reports naming product code DWZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K882383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K882383: Maggi Series Ultra. Needle, Biopsy/Catheter Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882383
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026